Table of Contents - Issue

Volume 1 | Issue 2

This issues of Clinical Research journals has articles, case studies and article reviews related to health science. In addition, there are numerous articles based on safety and effectiveness of medications, devices, diagnostic products and treatment regimens intended for human use.

Abstract:

A Periodic Safety
Update Report (PSUR) is intended to provide an update of the worldwide safety
experience of a VMP to Competent Authorities at defined time points
post-authorisation. At these times, MAHs are expected to provide succinct
summary information on all adverse events together with a critical evaluation
of the benefit-risk balance of the VMP in the light of any new or changing
pharmacovigilance information. This evaluation is necessary to ascertain
whether further investigations need to be carried out and/or whether changes
should be made to the SPC or other product information. For VMPs:

purely nationally authorized;

authorized within the scope of Directive 87/22/EEC (ex-concentration
procedure);

that have benefited from the MRP or the DCP in accordance with
Directive 2001/82/EC;

that
have been subject to referrals considered under Articles 36, 37 and 38 of
Directive 2001/82

PSURs should be submitted to DGV in accordance with point 2 of
Article 110.º of Decreto-Lei n.º 148/2008, from 29th July, as amended by
Decreto-Lei n.º 314/2009, from 28th October. The requirement for
the submission of a PSUR applies irrespective of whether the VMP is marketed or
not.

Any
failure of a key PSUR process will have the opposite effect - a poor quality
report that will give little insight into emerging safety signals or provide
misleading information that can adversely affect public health. A pragmatic
approach that will avoid or minimise these pitfalls includes the following:
adequate resource planning, training, development of 'scripts' designed to
maximize the capture of key information for medically important reactions,
standardized and harmonized Medical Dictionary for Regulatory Activities
(MedDRA) coding procedures, pre-specified search criteria for data retrieval,
ongoing medical review, and metrics to evaluate the effectiveness and
efficiencies of these processes. With these quality measures in place, the
utility of the PSUR as an effective pharmacovigilance tool is enhanced

Patient Safety: A Fundamental Aspect of Clinical Trials through A Review Of A Study On Canadian Adverse Events

Abstract:

Patient safety has
received growing attention worldwide sin last decade or two in clinical
research. Identification and immediate reporting of an Adverse Event (AE) has
always been one of the key parameters to assess and observer patient’s safety
in clinical research. Compromise to the patient safety was evident as critical
violation of the International Harmonization Conference (ICH) - Good Clinical
Practice (GCP) requirements of clinical research.

This review was
written after comprehensive and critical assessment of the research conducted
by G. Ross Baker et.al. This review provided a synthesis of key principles of
identification of AEs and determination of their preventability. It examined
detail article structure considering the sample size, research population and
relevance to the research topic. The review further critiqued on the article
authority and creditability of the journal to authenticate the research. This
review also commented on the other relevant advance researches conducted in the
area of AEs within clinical research as a detail comparison.

It was concluded in
this review that research conducted by G. Ross Baker et.al was critical in
terms of improving attention towards patient safety in clinical research and
community services.

Patient Safety: A Fundamental Aspect of Clinical Trials through A Review Of A Study On Canadian Adverse Events

Abstract:

Background:
Bias might occur due to the clinical research study structures,
endogenous bias, and to the investigators’ intention, external bias, on
selecting only the positive outcomes and published them. So the publication
bias still widespread in TCM clinical, but TCM are not unique cases, therefore
study conclusions ought to be interpreted with caution.

Results:
The number of Chinese randomized trials registration increases from
1999 to 2012, as well as the countries where these Chinese trials registered.
As well as the frequency of the type of TCM intervention included in each
registry. Classification of disease based on the International Classification
of Diseases (ICD-10) has been used to classify medical conditions. Only
(46.1%)= 505 out of 1096 registered randomized trials were completed studies.
Only has found 29% of registered TCM trials presented selective
outcome-reporting bias in between the outcomes registered and the outcomes
published.

Conclusions: The
quality of TCM clinical trials have developed through prospective international
trial registration compared with previous methodological studies. Although
there are some inconsistencies between the registered trial protocols and
subsequent publications and inadequate reporting .Nevertheless it is indistinct
how the study designs have got better-quality.

Integrated Approach to Health Care Management By Stakeholders

Abstract:

The
term ‘Stakeholder’ is a broad term that applies to: People inside the
organization, but usually outside of the project team, who are in some way
affected by the project. Typically Stakeholders will be users of the output
from a project or benefit from its introduction. They may also have to change
their role, function or method of working as users of new systems, processes or
products.

Stakeholders
might also be external customers and suppliers, as they might be directly
affected by the changes resulting from a project. Stakeholders could include
those who identified the need for project activity.

Systematic Review: An Approach for Transparent Research Synthesis

Abstract:

A systematic review
is a literature review focused on a research question that tries to identify,
appraise, select and synthesize all high quality research evidence relevant to
that question. Systematic reviews of high-quality randomized controlled trials
are crucial to evidence-based medicine. An understanding of systematic reviews
and how to implement them in practice is becoming mandatory for all
professionals involved in the delivery of health care. Besides health
interventions, systematic reviews may concern clinical tests, public health
interventions, social interventions, adverse effects, and economic evaluations.
Systematic reviews are not limited to medicine and are quite common in other
sciences where data are collected, published in the literature, and an
assessment of methodological quality for a precisely defined subject would be
helpful.

With an
ever-increasing plethora of studies being published in the health sciences, it
is challenging if not impossible for busy clinicians and researchers alike to
keep up with the literature. Reviews summarizing the outcomes of various
intervention trials are therefore an extremely efficient method for obtaining
the “bottom line” about what works and what doesn’t. In his review we cover the
basic principles of Systemic review and meta-analysis. The important issues
that needs to consider while doing systematic reviews and meta-analysis are
outlined and some of the terms used in the reporting of systematic reviews and
meta-analysis such as odds ratio, relative risk, confidence interval and forest
plot

Serological Analysis to Delineate Between Gastric Atrophy and a Normal Health Stomach without Endoscopy

Abstract:

The article
"Serological Assessment of Samples from Patients Complaining of Dyspepsia"
by Dr. Stephen Mortlock is current article published in the Journal of
Gastrointestinal and Digestive Systems in October 2013. This review analyses
the article's structure, authority, currency, stability, objectivity and it
relevance to students and the health care industry. The review first summarize
the article. it then analysis the structure of the article, taking into
consideration the concept, methodology of the research, it accessible and the
technical flow of the article. The review will also critique the article on the
basis of its authority, currency, accuracy, objectivity and it stability. The
relevance of the article to in the academia and healthcare industry will also
be analyzed in the review. The review will analyze all the relevant data and
information (including diagrams) provided by the article before judging on the
credibility and the reliability of the article. In entirety, the article is
very well written, well structured, clear and relevant in to first year medical
students and general practitioners.

Serological Analysis to Delineate Between Gastric Atrophy and a Normal Health Stomach without Endoscopy

Abstract:

This review would
critically review the article, “Cognitive behavioural therapy for the treatment
of depression in people with multiple sclerosis: a systematic review and meta-
analysis”, published in BMC Psychiatry. The review would introduce the article
with a brief summary on the basis of available literature and further critique
the overall structure of the article. The review would provide information on
the accessibility of the article and highlights on current activities that are
ongoing in the area of research. In addition, it would also provide information
on the article by critically evaluating it on the basis of accuracy, relevance,
stability, objectivity and ultimately the credibility of the article set to be
reviewed. The cited references would also be critiqued on the basis of the
authenticity of the article and presentation of references for future
citations.

Brain Tumors – The Role of Monoclonal Antibodies Therapy and Challenges of Blood Brain Barriers

Abstract:

This review critically reviews the article monoclonal
antibodies therapy in neuro oncology The Brain tumors In applying mAb therapy
to brain tumors, both expectations and interpretation are seems difficult due
to blood-brain barrier (BBB).It prevents the antibodies from entry into the
brain but in case of brain tumors their entry is more complex. Brain tumors
(the target), antibodies (the magic), how antibodies attack tumor (the bullet)
and how they reach it (through blood brain barrier) are reviewed .With this as
introduction, practical experience with mAbs for brain tumor targets is by Clinical
experience with mAbs in brain tumor therapy indicates that it is less
inherently toxic than the conventional therapies and far safer for widespread
delivery

Three of the best-studied antibody/target combinations
Bevacizumab and GBM. It hard to define the effect of the antibody itself
on tumor growth bevacizumab primarily reduces edema. Other questions concern
response criteria. How to weigh overall survival as opposed to progression-free
survival; Rituximab and PCNSL Rituximab targets the common B-cell marker CD20
PCNSL, which is typically a B-cell lymphoma. Trastuzumab and metastastic breast
cancer Monoclonal antibodies (mAbs) serve as tumor-specific magic bullets in
two ways. As bullets, they would move through the blood to reach and attack
tumor targets and specificity of a single antibody would provide the magic ,
breast cancer patients respond to systemic mAb treatment, but then metastases
appear in the brain. Limitations of clinical trials and drawbacks of
pre-clinical models interpretation of clinical results difficult - increase in
overall or progression-free survival, or simply an improved quality of life,
are certainly of benefit to brain tumor patients- delivery strategies and tumor
sites

Brain Tumors – The Role of Monoclonal Antibodies Therapy and Challenges of Blood Brain Barriers

Strategy of Contextual Behavioral Science

Abstract:

This review
critically reviews the article ‘Contextual Behavioral Science: Creating a
science more adequate to the challenge of the human condition’ in the journal
Science Direct Journal. The review will first summarise the article. Secondly,
it will briefly analyse the effectiveness of the article’s structure,
investigating how the information is set out and whether the reader can access
it efficiently. Thirdly, the review will critique the article, evaluating its
authority, currency, accuracy. Overall the article was well written, clear and
relevant.

Strategy of Contextual Behavioral Science

References:

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Abstract:

The
review of the article identifies Tuberculosis (TB) as an infectious disease
which is known worldwide with reference to India being the second largest
populated country in the world. Secondly it identifies Acid Fast Bacilli using
Zielh-Neelson (Z-N) staining in a clinical laboratory for the identification of
TB using the best possible method to obtain secretions from the lower airways
of patients as compared to bacterial identification which is normally used.

Various
diagnostic methods and materials used to evaluate the article authority and
accuracy will be outlined which includes sample study, period of examination,
ethical practices prior starting the study, study protocol, study design,
inclusion and exclusion criteria carried out systematically under sterile
conditions.

Analysis of AFB
smear will be explained and presented using tables which are instrumental in
the identification of other diagnostic methods like sputum smear microscopy and
X-ray method. Conclusion of the study will be based on the safest method for
identification of the organism, which is cost effective and has the potential
to offer treatment to the suspected patients. On the other hand, the article
has obtained its objectivity and coverage by using various ethical committees
and by declaring no conflict of interest among the authors who have contributed
equally to the study.

Finally, the
evaluation of the article will be carried through the use of well designed and
précised questionnaires, a case sheet proforma plus relevant referees attached
to the article to aid more understanding.

Abstract:

The
review will assess the article: ‘Panax ginseng C.A Meyer root extract for
moderate Chronic Obstructive Pulmonary Disease (COPD): study protocol for a
randomised controlled trial’, published in 2012 by Xue et al. in the E-journal,
Trials, volume 12 number 164. The assessment will focus on the knowledge
contribution of the article to the field of translational medicine and evidence
based research for use of Complementary and Alternative Medicine (CAM).

Translational
medicine, a research dissemination tool for advancing gains of basic laboratory
discoveries to populations via clinical studies, has come to be a very useful
tool for the practice of conventional medicines. This paradigm has also found
usefulness as an emerging trend in the development and practice of CAM. CAM,
though older than conventional medicine, have found rebirth in the healing
sphere owing to public demand and based on successful psychometric evaluations
using various rigorous study designs of Randomised Controlled Trials (RCT).

The goal of
designing a study protocols is to obtain a tool for measuring and evaluating
how an intervention, medical device or diagnostic contribute to improvement in
health status or knowledge. Hence, this review will assess the scientific
rigour and proof of principles demonstrated by the author in developing the
study design. The article will be summarised, assessed on presentation
effectiveness and the depth of literature on current knowledge. A critique on
authority, currency, relevance, accuracy, objectivity and stability will be
carried out and the conclusion will present the statement of scientific value
of the article.